The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.
Serious Adverse Events
Serious Adverse Events related to the study procedure and/or study device defined as Grade III or greater according to Clavien-Dindo Classification
Time frame: Through study completion, 12 months post procedure
Average Change in HbA1c
Mean change in HbA1c from baseline to 1-year. If rescue treatment is initiated, the last HbA1c value before initiation of rescue treatment is used for assessment of the primary effectiveness endpoint.
Time frame: 12 months post procedure
Proportion of Subjects Achieving HbA1c < 7%
Proportion of subjects achieving HbA1c \< 7% without initiating rescue treatment at 1-year
Time frame: 12 months post procedure
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